EHRs Are Not A 'Digital Menace'

Healthcare IT can compromise patient safety, but studies show that lack of it may present an even greater risk.

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"The lottery is a tax on people who don't understand mathematics."

It's one of my favorite truisms because it aptly describes the magical thinking that so many people buy into about their chances of winning that $100 million jackpot, despite the fact that a person is more likely to get hit by lightning on his birthday.

This truism also applies to misconceptions about lots of other probabilities -- like the risk of developing a serious reaction to the measles vaccine versus the benefits of averting a life-threatening measles epidemic. Or the risk of getting the wrong medication due to an EHR glitch versus the benefits that come from replacing paper with digital files. Those benefits include better care coordination, zero risk of misreading physicians' illegible handwriting, and monitoring of drug/drug and drug/food interactions.

Probability is not one of our strong suits as a nation, and unfortunately that weakness plays into the mass media's tendency to run scary headlines that talk about the "digital menace."

A recent Bloomberg article, "Digital Health Records' Risks Emerge as Deaths Blamed on Systems", illustrates my point. The piece starts out describing the case of an 84-year-old woman who was rushed to the hospital for a suspected stroke and eventually died because, says her physician son Scot Silverstein, one of the drugs she needed had inadvertently dropped off the medication list in the hospital's EHR system.

Silverstein is quoted as saying, "I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway ... My mom would be around right now, bopping around, if they had simply not forgotten to give her $2 of medicine."

Dr. Silverstein certainly had reason to be indignant and to hold the hospital involved accountable, but anyone reading this article might easily jump to the conclusion that EHRs are a huge threat to life and limb. Just how much of a threat are they?

There are no large-scale controlled studies that I know of that do a head-to-head comparison of paper and digital medical records systems, but there's enough available data to estimate the relative risks of each.

In 1999, The Institute of Medicine published its now-famous report "To Err is Human: Building a Safer Health System." Based on an analysis of adverse events in two large studies conducted in the mostly pre-EHR 1990s, IOM estimated that between 44,000 and 98,000 Americans die each year from medical errors. The original studies that this range was based on found adverse events occurred in 2.9% to 3.7% of hospitalizations.

On the other hand, a 2012 report from the Office of the National Coordinator for Health Information Technology (ONC), citing another IOM analysis, found that health information systems were involved in less than 1% of reported errors. Similarly, the Pennsylvania Patient Safety Authority looked at patient safety as it relates to EHRs and found that only 3,900 of 1.7 million reports were found to involve health IT.

So let's do the math: The Pennsylvania report suggests 0.2% of adverse events involve HIT, vs. at least 2.9% in the paper world. Put another way, the probability of being harmed if your medical records reside in paper files is about 14 times greater than if they were in electronic form.

That's not to trivialize the problems that can go wrong in EHR systems that would probably not happen in a paper world. A case in point: When a physician is given a drop-down menu with an alphabetical list of medications to choose from, it's easy to accidently click on Ativan instead of Atenolol if they are listed next to one another.

And the Bloomberg article rightly points out that while providers and manufacturers must report defective medical devices, software companies that make electronic medical records are under no such requirement.

To be sure, hospitals and vendors should be held responsible for the functionality and proper use of EHRs. With that in mind, ONC recently published a detailed plan to encourage all stakeholders to report health-IT related incidents and hazards to patient safety organizations. On a similar note, the federal government does need to write enforceable regulations, as John Halamka, MD, CIO at Beth Israel Deaconess Medical Center in Boston recently pointed out.

But even with such safeguards in place, clinicians and patients both need to put the risks in perspective. The statistics suggest a lot more patients are harmed by paper than by digital records.

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IOM also admits that major impediments to knowledge of health IT risks exists and is unacceptable:

Several reasons health ITGă˘related safety data are lacking include the absence of measures and a central repository (or linkages

among decentralized repositories) to collect, analyze, and act oninformation related to safety of this technology. Another impediment togathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health ITGă˘related adverse events. These barriers limit usersGăÍ abilities to share knowledge of risk-prone user interfaces, for instance through

screenshots and descriptions of potentially unsafe processes. Inaddition, some vendors include language in their sales contracts andescape responsibility for errors or defects in their software (i.e., Găúhold harmless clausesGăą). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledgeof health ITGă˘related patient safety risks. These barriers to

I was a reviewer of the PA Patient Safety Authority report, authored by ECRI. As at my essay at http://hcrenewal.blogspot.com/... , recommended inclusion of a "limitations" section. That recommendation was accepted.

The attempt was made, as acknowledged in the study, to glean information about EHR-related events from, in large part, textual analysis of narrative inthe hopes that the reporter recognized the role of IT, and reported it

using terms that could be detected by the search algorithms. In other words, the data was not "purposed" for this type of study.

It is axiomatic that one cannot find data that is simply not present, no matter how fancy the search algorithm. Further, passive analysis of clinical IT risk/harms data in an industry where lack of knowledge of causation and misconceptions abound will produce only partial results that suggest further study is needed, and not give an indicator of just how incomplete the results are.

Perhaps more valid is the later ECRI Deep Dive study where, in volunteer reports from just 36 of their member PSO hospitals, in just 9 weeks 171 health IT mishaps were reported, 8 of which caused harm and 3 of which may have contributed to or caused patient death. See "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" at http://www.ama-assn.org/amedne... . In a mere 9 weeks from 36 member PSO hospitals, ECRI received voluntary reports (generally 5% of the true total) of 171 health IT mishaps, 8 of which caused patient harm, and 3 of which may have caused the patient's death.

If one does the math, extrapolating from figures like that, the results are concerning.

We need far more study of this experimental technology, especially with studies like the ECRI Deep Dive appearing. We also need to proceed with far more caution and not make blanket statements like "EHRs are not a digital menace." In theory, they are not; in practice, the jury is not yet out due to insufficient data. However red flags are appearing that cannot be denied.

It strikes me that the most dangerous part of implementing EHRs is the conversion from paper - the transition and transcription where errors like the omission of information about a prescription can creep in.

I wondered if that might be the case with Dr. Silverstein's mother, but apparently not (the prescription was listed in EHR one day and not the next, according to his account).